Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food; Extension of Comment Period for Information Collection Provisions

This Proposed Rule document was issued by the Food and Drug Administration (FDA)

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 1, 16, 106, 110, 114, 117, 120, 123, 129, 179, and 211
[Docket No. FDA-2011-N-0920]
RIN 0910-AG36

Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food; Extension of Comment Period for Information Collection Provisions

Agency

Food and Drug Administration, HHS.

Action

Proposed rule; extension of comment period for information collection provisions.

Summary

The Food and Drug Administration (FDA or “we”) is extending the comment period for the information collection related to the proposed rule on “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food” that appeared in theFederal Registerof January 16, 2013. In the preamble to the proposed rule, FDA requested comments on the information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments on the information collection provisions associated with the rule.

Dates

The comment period for the proposed rule published January 16, 2013 (78 FR 3646), is extended. Submit either electronic or written comments by May 16, 2013.

Addresses

To ensure that comments on information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All comments should be identified with the title “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food.”

For Further Information Contact

Domini Bean, Office of Information Management, Food and Drug Administration, 1350 Picard Dr., PI50-400T, Rockville, MD 20850, Domini.Bean@fda.hhs.gov.

Supplementary Information

I. Background

In theFederal Registerof January 16, 2013 (78 FR 3646), FDA published a proposed rule entitled “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food” with a 120-day comment period on the provisions of the proposed rule and a 30-day comment period on the information collection provisions that are subject to review by OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Comments on the provisions of the rule and on the information collection provisions will inform FDA's rulemaking to modernize the regulation for “Current Good Manufacturing Practice In Manufacturing, Packing, or Holding Human Food” and to add requirements for domestic and foreign facilities that are required to register under the Federal Food, Drug, and Cosmetic Act to establish and implement hazard analysis and risk-based preventive controls for human food.

OMB and FDA have received two requests for a 90-day extension of the comment period for the information collection provisions of the proposed rule. The requests conveyed concern that the current 30-day comment period does not allow sufficient time to develop a meaningful or thoughtful response to the information collection provisions submitted to OMB under the Paperwork Reduction Act of 1995.

We have considered the requests and are extending the comment period for the information collection for 90 days, until May 16, 2013. We believe that a 90-day extension allows adequate time for interested persons to submit comments without significantly delaying rulemaking on these important issues. A 90-day extension also will make the comment period for the information collection provisions the same as the comment period for the provisions of the proposed rule.

II. Request for Comments

Interested persons may either submit electronic comments regarding the information collection to oira_submission@omb.eop.gov or fax written comments to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285. All comments should be identified with the title “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food.”

Dated: February 13, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-03732 Filed 2-15-13; 8:45 am]
BILLING CODE 4160-01-P
 
 
Comment Period Closed
Nov 15 2013, at 11:59 PM ET
ID: FDA-2011-N-0920-0013
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Document Information

Date Posted: Feb 19, 2013
RIN: 0910-AG36
CFR: 21 CFR Parts 1, 16, 106, 110, 114, 117, 120, 211
Federal Register Number: 2013-03732
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Comments

66
Comments Received*
See attached file(s)
Members of the Apple Processors Association (APA), who process quality apple products from domestically grown whole apples, support the FDA proposed rules to...
Please find attached comments from the Academy of Nutrition and Dietetics. -Pepin Tuma

* This count refers to the total comment/submissions received on this document, as of 11:59 PM yesterday. Note: Agencies review all submissions, however some agencies may choose to redact, or withhold, certain submissions (or portions thereof) such as those containing private or proprietary information, inappropriate language, or duplicate/near duplicate examples of a mass-mail campaign. This can result in discrepancies between this count and those displayed when conducting searches on the Public Submission document type. For specific information about an agency’s public submission policy, refer to its website or the Federal Register document.

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